Mechanical Design Engineer - NPD (Medical Device)

Job Title: New Product Development (NPD) Engineer Medical Devices

Location: Irvine, CA 92618
Experience: 5 8 years
Industry: Medical Devices

Job Summary

We are looking for an experienced NPD Engineer to support the development and design of electro-mechanical systems and components for medical device products. The ideal candidate will have strong experience in New Product Development, electro-mechanical design, automation, CAD, and medical device regulatory requirements.

Key Responsibilities

Design and develop electro-mechanical systems, assemblies, and components for new products.

Perform system integration of mechanical and electrical components.

Identify and apply stepper motors, motor drivers, sensors, and PLC programming in product designs.

Support mechanical, electromechanical, and developmental design activities with limited supervision.

Contribute to New Product Development (NPD) projects from concept through development.

Work with industrial automation, robotics, and precision instruments.

Create and modify designs using SolidWorks/CAD and apply GD&T principles.

Support design activities in compliance with Good Manufacturing Practices (GMP) and applicable medical device standards.

Apply knowledge of ISO 13485, Medical Device Regulatory Standards, MDD, and MDR.

Utilize statistical analysis and Design of Experiments (DOE) techniques where applicable.

Prepare and maintain engineering documentation and project-related records.

Collaborate with cross-functional teams including engineering, quality, manufacturing, and project management.

Must-Have Skills

Bachelor's degree in Engineering, Mechanical, Biomedical, Mechatronics, or Electromechanical Engineering.

5 8 years of technical/engineering experience, preferably in NPD and the medical device industry.

Strong experience in product development / New Product Development (NPD).

Hands-on experience with electro-mechanical system and component design.

Experience with SolidWorks/CAD and GD&T.

Knowledge of PLC programming, stepper motors, motor drivers, and sensors.

Experience with industrial automation, robotics, or precision instruments is a plus.

Knowledge of GMP and medical device regulatory requirements.

Working knowledge of ISO 13485, MDD, MDR, and related medical device standards.

Knowledge of DOE and statistical analysis is preferred.

Strong project planning, organizational, communication, and interpersonal skills.

Proficiency with Microsoft Office, Word, Excel, PowerPoint, email, and web-based tools.

Preferred Qualifications

Experience developing regulated medical device products.

Experience working with automated or robotic electro-mechanical systems.

Experience supporting products from concept/design through manufacturing and commercialization.

Strong understanding of engineering documentation and design processes.

Education

Bachelor's degree in Engineering, Mechanical, Biomedical, Mechatronics, Electromechanical Engineering, or a related technical discipline.